A Study of GW842166 in Adults With Osteoarthritis Pain

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A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee

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Ages Eligible for Study:

40 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

male or female outpatient, >= 40 years of age

meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months

meets ARA functional status requirements

meets WOMAC pain subscale score requirements

has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen

Exclusion Criteria:

any pre-specified clinical/biological/ECG abnormality

any pre-specified drug sensitivity

history of peptic ulceration or GI bleeding

use of protocol-specified medications

secondary cause of knee OA

lower extremity surgery within 6 months of screening

use of analgesics other than allowed per protocol

use of corticosteroids or hyaluronan outside of allowed window prior to screening